With the continuous development of the coronavirus epidemic in the United States, the increase in the sales of medical supplies in the United States has begun to be in short supply, and the American people have also set off a “rush buying” supermarket. According to the “Global Times” report on March 4, data showed that last week the sales of medical masks in the United States rose 78%, sales of hand sanitizers rose 54%, sales of thermometers rose 34%, disinfection spray sales rose 19%.
The vast majority of these products are imported from China. Many retailers have begun to restrict purchases for key products. Large chain store Depot has announced a limit of 10 masks per consumer.
On March 5, the U.S. provided tariff reductions for 27 US companies importing more than 100 medical-related products from China, which are applicable to masks, disinfection products, isolation clothing, etc. A large number of importers have gone crazy from the past three weeks. China imports medical and epidemic prevention supplies.
The United States medical equipment (medical care supplies) falls under the scope of the Food and Drug Administration (FDA).
The FDA divides medical supplies into three categories and adopts different management and controls.
The first category of medical supplies: general control, the product must meet the general requirements.
The second category of medical supplies: special control, products must meet functional standards.
The third category of medical care supplies: the most stringent control, must be approved before listing.
We will receive countless questions about whether I can import medical-grade, surgical grade, N95 medical, and medical masks from China. If you read the following, you will find the answer.
The latest information about FDA issues when import and ship from China about medical supplies.
Many US imports and exports, because of the interests of the drive, busy importing a large number of medical, surgical-grade masks from China, but the goods arrived in the United States airport could not be cleared normally, resulting in damage to reputation, because there is no FDA ID.
Many American importers import medical products from China, thinking that their Chinese suppliers can provide FDA certification, but they neglected that they also need FDA ID, and some people did apply for FDA ID, but did not complete 510K, The product still cannot be sold in the US market.
Therefore, we currently recommend that customers in the United States import protective masks. If you read the following article, you cannot obtain the corresponding qualification. Currently, more than 70% of American masks are protection grade, and there are not so many formal medical masks.
For example, in hospital supplies, bandages are the first type, temperature-adjustable water cushions are the second type, and chemical cold medicine kits (snake bite first aid kits) are the third type. In physical physiotherapy equipment, the patient’s turning bed is the first type, the physiotherapy massager is the second type, and the ultrasonic muscle syringe is the third type.
Management of medical supplies imported from China before entering the U.S. market
Any kind of medical supplies imported from China is registered with the FDA by the US importer (or wholesaler) using the FDA2891 form 30 days before entering the United States. The FDA grants a 7-digit registration number (importer Registration number), and the process is complete. When importing, this number should be listed on the invoice to facilitate FDA clearance and entry.
Countless US importers have asked us if we can import medical, surgical-grade masks from China. If you do not register for an FDA ID, the answer is no!
Manufacturer Product Registration
In addition to the above registration procedures, the FDA also requires suppliers to use the FDA2892 form to register the variety of equipment and supplies sold in the United States. The FDA issued a 6-digit product registration number prefixed with a letter, which is the same as the registration number. It is indicated on the import commercial invoice, which is conducive to FDA clearance of medical supplies imported from China.
510K declaration for medical products imported from China before listing
Because this declaration is provided for in Section 510 (K) of the Act, it is called a 510K declaration. The content of the declaration is detailed information about this product and the effectiveness and safety that must be stated. For any medical care products that have been listed in the United States for the first time, or similar products have been previously marketed, but there are major or substantial changes, they must be reported to the FDA 90 days before marketing. The FDA reviews this submission and determines the classification of this product within 90 days.
Generally, if the product is classified into the first or second category or the product is considered to be the same as a safe and effective product already on the market, it can be approved for immediate marketing. For the third category, the applicant must further complete the “pre-market approval procedures”. The FDA grants a 6-digit letter-numbered number, which the importer indicates on the invoice to facilitate customs clearance.
It should be noted that once the FDA checks and declares, the product is classified as a third category. Whether it is manufactured in the country or imported from a foreign country, the manufacturer must perform pre-market approval (referred to as PMA for short) with detailed scientific evidence and clinical practice. The results revealed to the FDA that this product is safe and effective, which is the most stringent level for the third category of medical devices (medical supplies).
Quality system requirements for medical device production
The production of medical supplies has a set of “qualified factory specifications” (referred to as GMP). Factories producing medical supplies must comply with FDA GMP regulations (21CFR820) to avoid producing substandard products.
These regulations cover a wide range: factory equipment, design, maintenance standards, control of packaging, marking, maintenance of workshops, training of personnel, record keeping, etc. have detailed regulations. The FDA not only conducts inspections in the United States’ domestic medical equipment manufacturing plants, but also conducts field investigations abroad (with the consent of foreign governments). Although foreign manufacturers were detained for exporting to the United States because they did not comply with the GMP, but after efforts to improve and verification by the FDA, they could be removed from the list of automatic detentions and resume normal import treatment.
Marking of medical devices
The US requirements for medical equipment and various types of medical care products are “safe” and “effective.” Medical devices listed in the United States must be “qualified” and “accurately marked.” Any medical care supplies and medical equipment must be properly marked, including the name or address of the manufacturer or distributor, safety instructions and precautions. Certain professional equipment must be marked for use only by the licensee. If the mark is false or misleading, or the mark is not described in English, does not include due content or does not have sufficient instructions for use, warning or reminder, etc., it is an inappropriate mark and it is also denied entry into the market.
What is the FDA?
FDA is the abbreviation of the U.S. Food and Drug Administration. It is an international medical review authority, authorized by the US Congress, the federal government, and the highest law enforcement agency specializing in food and drug management. The FDA is a government health monitoring agency dedicated to protecting, promoting, and improving national health, consisting of professionals including doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians. FDA-certified foods, medicines, cosmetics, and medical devices are safe and effective for the human body. In nearly a hundred countries such as the United States, only clinically approved clinical applications can be achieved with materials, devices, and technologies that have been approved by the FDA.
How to Import Medical Devices from China to pass the FDA Certification:
FDA’s management of medical devices is carried out through the Center for Devices and Radiological Health (CDRH), which oversees the production, packaging and distribution of medical devices and conducts business activities in compliance with the law.
Medical devices range from medical gloves to cardiac pacemakers under the supervision of the FDA. According to medical uses and possible harm to the human body, the FDA classifies medical devices into categories Ⅰ, Ⅱ, and Ⅲ. The more category supervision.
If the product is a novel invention that did not exist on the market, the FDA requires manufacturers to perform rigorous human experiments and have convincing medical and statistical evidence that the product is effective and safe.
FDA certification of medical devices, including manufacturers’ FDA registration, product FDA registration, product-market registration (Form 510 registration), product market review approval (PMA review), labeling and technical transformation of medical devices, customs clearance, registration, pre-marketing The report must submit the following materials:
(1) Five finished products in complete packaging,
(2) Device structure drawing and text description,
(3) the performance and working principle of the device;
(4) Safety demonstration or test materials of the device,
(5) Brief introduction of the manufacturing process,
(6) Summary of clinical trials,
(7) Product description. If the device has radioactive energy or releases radioactive material, it must be described in detail.
When food and medicine and medical equipment imported from China do not meet the regulations, penalties:
“Automatic detention” is a major measure implemented by the US Food and Drug Administration (FDA) on imported food. In short, goods that are declared as “automatic detention” by the FDA must pass through the United States when they arrive at US ports. After passing the laboratory test, they are allowed to enter the United States for sale.
Due to the small number of FDA personnel, facing the situation of imported food, drugs, cosmetics, and other products with large specifications and large quantities, it is impossible to conduct batch-by-batch inspections, but only random inspections. Generally, the rate of random inspections is 3-5%. If the products pass, the batch of products can be released; if the samples checked are unqualified, the batch of products will be “detained” and processed.
If the problems found in the inspection are general problems (such as unqualified trademarks, etc.), the importer can be allowed to be released after the local inspection is passed after the local processing; if the problems found in the inspection are related to sanitary quality, it is not allowed Released, or destroyed locally, or imported by the importer back to the exporting country (region), and may not be transferred to other countries (regions).
In addition to spot checks, there is another measure, that is, for imported products with potential problems, they must be inspected batch by batch instead of spot checks when entering the customs. This is the “automatic detention” measure, and the FDA announced that it will adopt “automatic detention” for a certain product. Measures can be based on the following reasons:
1. At least one sample has been found to have significant harm to human health after inspection, such as harmful elements, pesticide residues exceeding standards, the presence of toxins, pathogenic microorganisms, chemical pollution, etc., which violated the relevant regulations on low-acid canned foods or contained Declared ingredients such as pigments.
2. If there is information or historical records, or notifications from relevant authorities in other countries, indicating that products from a certain country or region may cause harm to human health, and the FDA has evaluated the above sources to confirm that the products are in The United States may also cause the same hazard. The FDA can also announce “automatic detention” measures for such products.
3. Multiple samples failed the inspection, but there is no obvious harm to human health, such as deteriorated odor, inclusions, unqualified labels, etc., can be announced to the manufacturer, exporter or country (region) respectively as follows: “Automatic detention” measures:
(l) If a manufacturer or exporter exports products to the United States, at least 3 batches of goods were found to be detained by the FDA in 6 months, and they should be “detained” and processed, and the unqualified samples exceeded 25% of the tested samples. Then the FDA will take “automatic detention” measures for such products exported to the United States by manufacturers or exporters;
(2) If at least 12 batches of goods exported to the United States from a certain country or region are found to be problematic by the FDA during the 6 months, they shall be “detained”
Frequently Asked Questions about FDA:
Question 1: Which agency issued the FDA certificate?
A: There is no certificate for FDA registration. Products registered with the FDA will obtain a registration number. The FDA will return a letter to the applicant (with the signature of the FDA chief executive), but there is no FDA certificate.
Question 2: Does the FDA need a designated accredited laboratory test?
A: The FDA is an enforcement agency, not a service agency. If someone says that they are FDA-accredited laboratories, then he is at least misleading consumers, because the FDA has neither a service-oriented certification body or laboratory for the public, nor a so-called “designated laboratory”. The FDA, as a federal law enforcement agency, cannot engage in such a role as a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity, but will not “designate” or recommend a specific one or several to the public.
Question 3: Does an FDA registration necessarily require a U.S. agent?
A: Yes, Chinese applicants must appoint an American citizen (company/community) as their agent when registering with the FDA. This agent is responsible for the process services located in the United States and is the medium to contact the FDA and the applicant.
Question 4： Does Medical mask need the FDA registration approval required or not？
A:Medical masks as Class II medical devices require FDA510 (k) registration before market，many US importer ignore this key point when importing medical masks to US，this is a big mistake.
Medical N95 masks need to meet NIOSH’s requirements for N95 masks and also meet FDA medical mask standards. It is also a Class II medical device. When it is used to prevent specific diseases / infections and filter viruses or bacteria, it is necessary to apply for FDA510 (k).
“510 (k)”, also known as pre-market registration, is a pre-market report submitted to FDA. According to FDA requirements, a small number of Class I and most Class II medical devices must submit a 510 (k) application at least 90 days before they are marketed in the United States
Question 5：Why do personal protective masks have to obtain NIOSH testing registration in the United States?
According to the NIOSH guidelines, companies need to send samples to the NIOSH laboratory for testing, and submit technical information (including quality system parts) to the NIOSH document review. NIOSH classifies its registered anti-particulate masks into 9 categories, and specific tests are performed by NPPTL (National Personal Protective Technology Laboratory) laboratory under NIOSH. The main test indicators include exhalation resistance test, exhalation valve leakage test, inhalation resistance test, filtration efficiency test
Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer，protective gloves, goggles from China.
One-stop guide&unserstanding, update 2020, All you need to know!（All legal, with all types of supplier resources attached！！！）